
Ornim Inc. in Santa Clarita, California said it received clearance from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S.
Ornim says the FDA action clears the CerOx 3210F monitor for use as a non-invasive monitor of blood flow in tissue of adults. The device has already been cleared for for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle.
A 510(k) submission, named after the applicable section of FDA’s enabling legislation, demonstrates that the device to be marketed is at least as safe and effective — substantially equivalent — to a device that is already legally marketed. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
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